Clinical Trial: Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine, Inactivated, Dried, TSI-GSD 104, Lot 2-1-89, in Healthy Adult Subjects at Risk of Exposure to Eastern Equine Encephalitis Virus
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Phase 2 Open-Label Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine, Inactivated, Dried, TSI-GSD 104, Lot 2-1-89, in Healthy Adult Subjects
Brief Summary: This study is being conducted to collect safety and immunogenicity data for the EEE vaccine.
Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Number of Adverse Events. [ Time Frame: 5 Years ]
- Number of subjects that develop titers ≥ 1:40 [ Time Frame: 5 Years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Geometric mean of plaque reduction neutralization test (PRNT) 80 titers [ Time Frame: 5 Years ]
Original Secondary Outcome: Same as current
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: January 11, 2016
Date Started: August 2016
Date Completion: February 2022
Last Updated: August 19, 2016
Last Verified: August 2016
